FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Luna 3D GEN2 Interbody Fusion System
K Number: K183560
·
Decision May 23, 2019
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
8
Review Days
154
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Basic Information
- Device Name
- Luna 3D GEN2 Interbody Fusion System
- K Number
- K183560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Benvenue Medical, Inc.
- Date Received
- December 20, 2018
- Decision Date
- May 23, 2019
- Product Code
- MAX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Benvenue Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201427 | Trivergent Spinal Fixation System | Oct 21, 2020 | Substantially Equivalent |
| K193172 | Luna XD Ti Interbody Fusion System | Jul 2, 2020 | Substantially Equivalent |
| K162431 | Luna 3D Interbody Fusion System | Nov 17, 2016 | Substantially Equivalent |
| K142023 | LUNA INTERBODY SYSTEM | Nov 20, 2014 | Substantially Equivalent |
| K141141 | KIVA VCF TREATMENT SYSTEM | Aug 14, 2014 | Substantially Equivalent |
| K132817 | KIVA VCF TREATMENT SYSTEM | Jan 24, 2014 | Substantially Equivalent |
| K070293 | BENVENUE VCF OSTEO COIL SYSTEM | Jul 10, 2007 | Substantially Equivalent |